🇺🇸
United States · US · US:68180-545_8c4a7a07-69ef-4c8c-8db1-a53c46eff737
Nystatin and Triamcinolone Acetonide
Orange BookUNIISPLATC A07AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA07AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1168180545021 TUBE in 1 CARTON (68180-545-02) / 30 g in 1 TUBE
- ndc1168180545031 TUBE in 1 CARTON (68180-545-03) / 60 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
BDF1O1C72E
NYSTATIN
RxCUI 7597
Orange Book
A208205
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "BDF1O1C72E",
"rxcui": "7597",
"inchikey": null,
"display_name": "NYSTATIN",
"substance_type": "mixture",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"50737729-a4a4-e747-e063-6394a90adcc5": {
"match": "brand_token",
"title": "NYSTATIN SUSPENSION [KESIN PHARMA CORPORATION]",
"spl_version": "1",
"published_date": "2026-06-01"
}
},
"productid": "68180-545_8c4a7a07-69ef-4c8c-8db1-a53c46eff737",
"productndc": "68180-545",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "208205",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "100,000 UNITS/GM;0.1%",
"product_no": "001",
"approval_date": "May 31, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NYSTATIN; TRIAMCINOLONE ACETONIDE",
"proprietary_name": "Nystatin and Triamcinolone Acetonide",
"active_ingred_unit": "[USP'U]/g; mg/g",
"application_number": "ANDA208205",
"marketing_category": "ANDA",
"nonproprietary_name": "Nystatin and Triamcinolone Acetonide",
"start_marketing_date": "20181129",
"active_numerator_strength": "100000; 1"
}Related drugs
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